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CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
Date:9/10/2010

nts undergoing cardiac surgery procedures [Creswell 1993; Auer 2005; Echahidi 2008]. A recent retrospective analysis of more than 16,000 patients with no history of atrial fibrillation who underwent CABG surgery found an association between new onset postoperative atrial fibrillation and a 21% relative increase in mortality, with the greatest negative impact seen in the long-term survival of women. [El-Chami 2010].

"Postoperative atrial fibrillation is a significant concern for patient outcomes," added James L. Cox, MD, Emeritus Evarts A. Graham Professor of Surgery, Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, MO, President and CEO, World Heart Foundation, and CorMatrix Scientific Advisory Board member. "Despite efforts over the last 30 years to reduce postoperative arrhythmias, we continue to see a high incidence level and increased risk of death for patients. Ongoing study of new approaches is both warranted and encouraging as surgeons strive to further advance our care of patients undergoing bypass surgery."

CorMatrix ECM for Pericardial Closure received 510(k) clearance from the FDA in 2006 for the reconstruction and repair of the pericardium. CorMatrix ECM supports tissue remodeling by allowing native cells to migrate and attach within the ECM. The body's natural healing processes result in the ECM material being gradually resorbed and replaced by native tissue. Preclinical data suggests that reformation of the pericardial space provides a solution for surgeons to reconstruct the pericardium and restore the normal anatomic structure. The prospective clinical trial is being initiated under an IDE to investigate the safety and effectiveness of implanting CorMatrix ECM for Pericardial Closure for a new clinical indication to reduce the incidence of new onset postoperative atrial fibrillation.

About Extracellular Matrix Biomaterial

The unique properties of extracellular matrix biomaterials were dis
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SOURCE CorMatrix Cardiovascular, Inc.
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